Preapproval Inspection and Submission to the FDA

Securing FDA approval for new drug applications (NDA), abbreviated new drug applications (ANDA), or premarket approval (PMA) for medical devices requires more than just a strong product—it demands strict adherence to current Good Manufacturing Practices (cGMPs) and regulatory compliance. This webinar provides an in-depth look at the FDA’s preapproval inspection process, ensuring your manufacturing, processing, packaging, and testing methods meet the highest regulatory standards. Gain critical insights into compliance with 21 CFR 210/211 (for drugs) and 21 CFR 820 (for medical devices), along with key factors that impact approval success. Learn how to prepare for FDA site inspections, address common compliance pitfalls, and optimize your submission strategy to avoid costly delays or rejections.

WHY YOU SHOULD ATTEND:

FDA preapproval inspections are a pivotal step in bringing pharmaceutical and medical device products to market. Non-compliance can result in application delays, warning letters, or even denials. This webinar will help you:

• Understand the FDA’s expectations for preapproval inspections and submissions.
• Identify critical areas of compliance for manufacturing, testing, and facility controls.
• Navigate common challenges in 21 CFR 210/211 and 21 CFR 820 adherence.
• Prepare your team for FDA on-site evaluations and establishment file reviews.
• Minimize regulatory risks and streamline your approval process for faster market entry.

AREAS COVERED:

• Comprehensive Understanding of FDA Preapproval Inspections – Requirements for NDA, ANDA, and PMA submissions
• Compliance with cGMPs – Mastering 21 CFR 210/211 (pharmaceuticals) and 21 CFR 820 (medical devices)
• Critical Inspection Focus Areas – Personnel, facilities, equipment, documentation, and validation readiness
• Risk-Based Approaches to Compliance – Implementing facility, product, and process risk assessments
• Handling FDA Inquiries & Material Rejections – Managing inspection triggers and post-market surveillance
• Pharmacovigilance & Preapproval Compliance – Understanding its role in ensuring product safety and regulatory approval
• Preparing for FDA On-Site Audits – Best practices for establishment file reviews and inspection readiness
• Ensuring Robust Documentation Practices – Strengthening records to support a smooth approval process

WHO SHOULD ATTEND:

• Senior Management in Pharmaceutical & Medical Device Companies
• Quality Assurance (QA) & Regulatory Affairs (RA) Professionals
• Pharma Development & Testing Teams
• R&D Scientists & Engineers
• Production & Operations Managers
• Compliance & Validation Teams
• Marketing & Business Development Teams
• Consultants & Regulatory Experts

Course Director: JOHN E. LINCOLN  

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.